A Study of Anal Cancer Development in HIV Infected People

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00107679
First received: April 6, 2005
Last updated: January 30, 2011
Last verified: July 2006

April 6, 2005
January 30, 2011
Not Provided
March 2006   (final data collection date for primary outcome measure)
Time to high-grade anal dysplasia or anal cancer
Not Provided
Complete list of historical versions of study NCT00107679 on ClinicalTrials.gov Archive Site
  • Time to anal cancer
  • time to low-grade or high-grade anal dysplasia
  • time to anal HPV infection
  • time to anal HPV infection with a specific strain, for types 16, 18, or 31
  • time to cervical HPV infection
  • time to cervical HPV infection with a specific strain, for types 16, 18, or 31
  • time to high-grade anal dysplasia
  • time from low-grade anal dysplasia to normal
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A Study of Anal Cancer Development in HIV Infected People
Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies.

Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV, compared to people with either disease alone. Studies that have investigated the effect of highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been contradictory and inconclusive. The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined. This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. At the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. Participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. These procedures will be repeated at each annual follow-up visit. Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes, whichever comes first.

Observational
Time Perspective: Prospective
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  • HIV Infections
  • Anus Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
560
Not Provided
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained.
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Current or prior history of anal or cervical cancer
  • Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107679
CPCRA 065G, SMART
Not Provided
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National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Calvin Cohen, MD, MSc Community Research Initiative of New England
National Institute of Allergy and Infectious Diseases (NIAID)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP